SUMMARY
Post# of 153903
(Total Views: 431)
Posted On: 05/22/2019 2:16:24 PM
Summary, sorry typing fast to get it on the board from my phone.
Production/Launch
-SYNEOS Health will be doing the drug launch, they have worked with 50 other BP co's and have a good resume.
Samsung - 1st batch takes 5 weeks then they can do a 15,000 Liter batch every 2 weeks. I think they said 1,000 Patient doses for 1 year on one batch
-Also congratulated Dr. Rae on convincing Samsung to not request 50MM upfront. said it is almost unheard of in BP
BLA
-Clincal BLA - June is best case July Possible
-CMC - August to December. He is going to lean on FDA to move it up so its not december
-FDA will be infomed in may of 525 dose as the planned dose
Colon - IND Filed in a weeks weeks (most likely sooner)
China - discussed in my previous post. they are well aware of IP and are taking steps combat this
Samsung Meeting - He is traveling to Korea to present to the board on a direct investment and do ceremony for signing they did a few weeks back.
MEDIA - Joked about how no one has ever heard of us and that will change soon.
Prostate Test - No Term sheet yet, but one should be coming soon.
NP's father-in-law has prostate cancer and might be be one of the first right-to-try for Leron. His Dr at OHSU was shocked this dr existed and gave him the letter for right-to-try.
MONO (I asked NP) - Start with 240 Patients to End up with 160 for study.
Up-list (I asked NP) - no plans to up-list in near-term, they needs 1.5 years worth of cash on hand. this we will get crushed if we do it too soon.
Production/Launch
-SYNEOS Health will be doing the drug launch, they have worked with 50 other BP co's and have a good resume.
Samsung - 1st batch takes 5 weeks then they can do a 15,000 Liter batch every 2 weeks. I think they said 1,000 Patient doses for 1 year on one batch
-Also congratulated Dr. Rae on convincing Samsung to not request 50MM upfront. said it is almost unheard of in BP
BLA
-Clincal BLA - June is best case July Possible
-CMC - August to December. He is going to lean on FDA to move it up so its not december
-FDA will be infomed in may of 525 dose as the planned dose
Colon - IND Filed in a weeks weeks (most likely sooner)
China - discussed in my previous post. they are well aware of IP and are taking steps combat this
Samsung Meeting - He is traveling to Korea to present to the board on a direct investment and do ceremony for signing they did a few weeks back.
MEDIA - Joked about how no one has ever heard of us and that will change soon.
Prostate Test - No Term sheet yet, but one should be coming soon.
NP's father-in-law has prostate cancer and might be be one of the first right-to-try for Leron. His Dr at OHSU was shocked this dr existed and gave him the letter for right-to-try.
MONO (I asked NP) - Start with 240 Patients to End up with 160 for study.
Up-list (I asked NP) - no plans to up-list in near-term, they needs 1.5 years worth of cash on hand. this we will get crushed if we do it too soon.
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